Duloxetine for Colorectal Cancer

Recruiting at 858 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.

Research Team

Ellen M. Lavoie Smith, PhD

Principal Investigator

The University of Alabama at Birmingham School of Nursing

Eligibility Criteria

This trial is for stage II-III colorectal cancer patients who are about to receive oxaliplatin treatment and have no prior neurotoxic chemotherapy, pre-existing neuropathy, seizure disorders, glaucoma, severe psychiatric conditions or substance abuse. They must not be on certain medications like MAOIs or strong CYP1A2 inhibitors and should not be pregnant.

Inclusion Criteria

I have stage II-III colorectal cancer and will start a specific chemotherapy regimen soon.

I do not have any nerve damage from any cause.

No serious eating disorder such as bulimia or anorexia

Exclusion Criteria

I am not taking medications like gabapentin for nerve pain and can stop them 7 days before treatment.

I stopped taking MAOI or other antidepressants 14 days before starting the treatment.

I am not taking strong medications that affect liver enzymes CYP1A2 and CYP2D6.

Treatment Details

Interventions

• Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor)

Trial Overview The trial is testing whether duloxetine can prevent peripheral neuropathy (pain, tingling, numbness) in patients receiving oxaliplatin for colorectal cancer. It involves comparing the effects of duloxetine with a placebo while monitoring quality-of-life through questionnaires.

Participant Groups

Group I: Phase III, Arm I (duloxetine hydrochloride) Experimental Treatment 5 Interventions

Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.

Group II: Phase II, Arm II (duloxetine hydrochloride) Experimental Treatment 5 Interventions

Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 60 mg (2 duloxetine capsules) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Group III: Phase II, Arm I (duloxetine hydrochloride, placebo) Experimental Treatment 6 Interventions

Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD and placebo (1 placebo capsule) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Group IV: Phase II, Arm III (placebo) Placebo Group 4 Interventions

Patients in Phase II receive placebo (1 placebo capsule) orally (PO) once daily (QD) during week 1, placebo (2 placebo capsules) PO QD weeks 2-16, followed by placebo (1 placebo capsule) PO QD during week 17 in the absence of unacceptable toxicity.

Group V: Phase III, Arm II (placebo) Placebo Group 4 Interventions

Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School